Antiseptic preparation of patient's skin for surgery conventionally includes a 30 second to a 2 minute scrubbing of the affected area with an antiseptic solution. Devices have been developed in an attempt to prevent solution dripping associated with these techniques, and to reduce the time required for application of the antiseptic solution.
Some existing liquid applicators house the liquid in a glass ampoule which is then crushed to activate the device and saturate the sponge. For example, Wirt (U.S. Pat. No. 5,658,084) and Tufts (U.S. Pat. No. 6,536,975) disclose two different ways to rupture/break a glass ampoule in order to activate an applicator. Glass ampoules are common, because glass is impermeable to ethylene oxide (EO), which is often used during a sterilization process for sterilizing applicators. Wirt and Tufts also disclose applicators comprising numerous parts, including parts for preventing glass shards from reaching a patient during the application process. The applicator bodies are rigid, allowing the antiseptic to freely flow (i.e., in an uncontrolled manner) to a sponge after activation and before application to a target surface.
As an alternate approach to using glass ampoules, applicators using plastic bodies with frangible plastic tips have been developed. In such constructions, the applicator body also functions as a container for the solution, eliminating the glass ampoule. These applicators consist of an applicator handle comprising the solution, a frangible tip, and an end cap that closes the applicator handle, opposite the tip. The tip is flexed or twisted to break off a weakened tip region. Such applicators are often complex to construct, and are formed of multiple assembly components.
For example, Kaufman (U.S. Pat. No. 7,614,811) and Margoosian (U.S. Publication No. 2012/0051829) both disclose plastic applicators made of multiple plastic components with frangible plastic tips and squeezable applicator handles. However, these applicators are difficult and costly to assemble, and have multiple weld seams and joints that are susceptible to failure. Kaufman (U.S. Publication No. 2014/0126949) discloses an applicator where the frangible tip and the container body are integrated into a single piece, manufactured using an injection molding process. However, the resulting single piece includes an open end that still requires a secondary capping operation, adding another component and increasing assembly cost.
Van Dyke (U.S. Pat. No. 5,229,061) discloses a dip molding process for producing a dispensing container that has a frangible portion that is broken away during use. The resulting molded dispensing container still has an open end which needs to be sealed or have a secondary end cap attached when the applicator is filled. This dip molding process uses a core or a mold in order to form the internal geometry, including the break region.
Weiler (U.S. Pat. No. 4,671,763) and Poynter (U.S. Pat. No. 7,028,862) are two examples of containers formed by a blow-fill-seal (BFS) process. Poynter discloses a removable cap, a frangible break line, and a cap chamber. When the removable cap is grasped and twisted, the frangible break line is fractured, and the removable cap is removed, allowing the contents of the container to be expelled.
D'Alessandro (U.S. Pat. No. 3,847,151) teaches a liquid dispensing device for antiseptically cleansing a surface. This device has a hollow handle, and a nozzle with a stress raiser so that the end portion of the nozzle may be ruptured, and a surrounding web. The device allows for a portion of the web to be bent or flexed (e.g., to 45 degrees) after rupturing the end of the nozzle to allow the handle and a user's hand to be kept away from the surface to be cleaned. However, such a stepwise fracturing and bending process can be unnecessarily and ergonomically cumbersome.
Margoosian (CA Patent No. 2796699) discloses a container body that can be formed by a BFS method. However, this container body is only a portion of a multi-component liquid dispensing applicator, requiring multiple assembly steps.
In summary, existing applicators are often difficult and costly to assemble, requiring numerous separate components, and include multiple weld seams and joints susceptible to failure.